On October 31, 1988, Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) which included specific standards for laboratories providing cytology services. On May 21, 1990, the Department published proposed regulations for implementing CLIA '88 with an open comment period of 90 days. These proposed regulations were developed by the Health Care Financing Administration (HCFA) with technical support from the Center for Disease Control (CDC). The CDC staff included health scientists and cytotechnologists. The comments received during the comment period were overwhelming in number and degree of concern with the regulations. A committee has been assembled to evaluate the comments and, accordingly, to emend the proposed regulations. I am providing the sole cytopathologist expertise to this panel.